THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
Device Facts
| Record ID | K093114 |
|---|---|
| Device Name | THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY |
| Applicant | Microgenics Corp. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | May 12, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
The DRI® Amphetamines Assay is intended for the qualitative or semiquantitative determination of amphetamine and methamphetamine in human urine. The assay has cutoff levels of 500 and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting amphetamine and methamphetamine in urine on automated clinical analyzers. The assay is calibrated with methamphetamine. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Device Story
DRI Amphetamines Assay is a liquid, ready-to-use homogeneous enzyme immunoassay for urine drug screening. Input: human urine sample. Principle: competitive binding between G6PDH-labeled drug and sample drug for fixed antibody sites. In absence of sample drug, antibody binds labeled drug, decreasing enzyme activity; in presence of sample drug, labeled drug is displaced, increasing enzyme activity. Output: spectrophotometric measurement at 340 nm (NAD to NADH conversion) proportional to drug concentration. Used in clinical laboratories on automated analyzers by trained personnel. Provides preliminary results requiring GC/MS confirmation. Benefits: rapid screening for amphetamine/methamphetamine abuse.
Clinical Evidence
No clinical studies were performed. Analytical performance was established via bench testing, including precision/reproducibility (n=80 per concentration), linearity (r=0.999), and method comparison against GC/MS using 160 clinical samples. Cross-reactivity and interference studies were conducted to validate specificity.
Technological Characteristics
Liquid, ready-to-use homogeneous enzyme immunoassay. Sensing principle: competition between G6PDH-labeled drug and sample drug for antibody binding sites. Energy source: spectrophotometric measurement at 340 nm. Connectivity: automated clinical analyzer. Storage: 2-8°C. Reagent stability: 60 days on-board.
Indications for Use
Indicated for the qualitative or semiquantitative screening of amphetamine and methamphetamine in human urine on automated clinical analyzers. Intended for use as a preliminary analytical test; requires confirmation by a more specific method like GC/MS.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- CEDIA® DAU Amphetamines Assay (K943993)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k093114
B. Purpose for Submission:
New Device
C. Measurand:
Amphetamines and methamphetamines in human urine
D. Type of Test:
Qualitative and semi-quantitative immunoassay
E. Applicant:
Microgenics, Inc.
F. Proprietary and Established Names:
DRI Amphetamines Assay
G. Regulatory Information:
1. Regulation section:
21 CFR § 862.3100, Enzyme Immunoassay, Amphetamine
21 CFR § 862.3610, Methamphetamine test system
2. Classification:
Class II
3. Product code:
DKZ - enzyme immunoassay, amphetamine
LAF - gas chromatography, methamphetamine
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4. Panel:
91 (Toxicology)
H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
The DRI® Amphetamines Assay is intended for the qualitative or semiquantitative determination of amphetamine and methamphetamine in human urine. The assay has cutoff levels of 500 and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting amphetamine and methamphetamine in urine on automated clinical analyzers. The assay is calibrated with methamphetamine.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
3. Special conditions for use statement(s):
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
4. Special instrument requirements:
The studies in the submission were performed on the Olympus AU680.
I. Device Description:
The DRI Amphetamines Assay is a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies, which can detect amphetamine and/or methamphetamine in urine with minimal cross-reactivity to various over-the-counter structurally unrelated compounds.
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J. Substantial Equivalence Information:
1. Predicate device name(s):
CEDIA DAU Amphetamine Assay
2. Predicate 510(k) number(s):
k943993
3. Comparison with predicate:
| Feature | CEDIA®Amphetamines Assay (K943993) | Thermo Scientific DRI® Amphetamines Assay (K093114) |
| --- | --- | --- |
| Intended Use | Qualitative and semi-quantitative detection of amphetamines and methamphetamines | Same |
| Cutoff | 500 and 1000 ng/mL | Same |
| Sample Type | Urine | Same |
| Reagents | Lyophilized
Two reagent assay (R1 and R2) | Liquid ready to use
Two reagent assay (R1 and R2) |
| Calibrators | Liquid ready-to-use
(0, 500, 1000, 3000, 5000 ng/mL) | Liquid ready-to-use
(0, 500, 1000, 3000, 5000 ng/mL) |
| Storage condition | 2-8°C | 2-8°C |
K. Standard/Guidance Document Referenced (if applicable):
CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods
CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement
CLSI EP9-A2, Method Comparison and Bias Estimation using patient samples
L. Test Principle:
The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine sample for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. In the presence of free drug, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and the enzyme activity. The enzyme activity is
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determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Drug free human urine samples spiked with d-amphetamine and d-methamphetamine individually at concentrations between 0 and 2000 ng/mL were tested for Inter-Assay precision in qualitative and semi-quantitative assays. Samples were tested following a randomized CLSI precision protocol for 40 runs in 20 days, n=80. The results are summarized below.
Qualitative Summary
| Analyte | Sample Concentration (ng/mL) | N | 500 Cutoff #Neg/#Pos | 1000 Cutoff #Neg/#Pos |
| --- | --- | --- | --- | --- |
| Amphetamine | 0 | 80 | 80/0 | 80/0 |
| | 150 | 80 | 80/0 | 80/0 |
| | 375 | 80 | 80/0 | 80/0 |
| | 625 | 80 | 0/80 | 80/0 |
| | 750 | 80 | 0/80 | 80/0 |
| | 1250 | 80 | 0/80 | 0/80 |
| | 1500 | 80 | 0/80 | 0/80 |
| Methamphetamine | 0 | 80 | 80/0 | 80/0 |
| | 150 | 80 | 80/0 | 80/0 |
| | 375 | 80 | 80/0 | 80/0 |
| | 625 | 80 | 0/80 | 80/0 |
| | 750 | 80 | 0/80 | 80/0 |
| | 1250 | 80 | 0/80 | 0/80 |
| | 1500 | 80 | 0/80 | 0/80 |
Semi-quantitative Summary
| Analyte | Sample Concentration (ng/mL) | N | Mean (ng/mL) | Within-Run CV% | Total CV% |
| --- | --- | --- | --- | --- | --- |
| Amphetamine | 150 | 80 | 145.9 | 6.2 | 6.9 |
| | 375 | 80 | 372.8 | 2.7 | 2.9 |
| | 625 | 80 | 683.9 | 1.6 | 2.0 |
| | 750 | 80 | 775.4 | 1.8 | 2.3 |
| | 1250 | 80 | 1317.9 | 1.8 | 2.2 |
| | 1500 | 80 | 1467.6 | 1.6 | 2.2 |
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| Methamphetamine | 150 | 80 | 168.4 | 4.4 | 5.5 |
| --- | --- | --- | --- | --- | --- |
| | 375 | 80 | 392.8 | 2.0 | 2.8 |
| | 625 | 80 | 626.1 | 1.5 | 1.9 |
| | 750 | 80 | 770.4 | 1.3 | 1.5 |
| | 1250 | 80 | 1284.1 | 1.2 | 1.5 |
| | 1500 | 80 | 1515.1 | 1.4 | 1.8 |
Intra assay precision and performance around the cutoff was verified by evaluating methamphetamine and amphetamine samples spiked to -50%, and -25% below the cutoff, cutoff, and +25%, +50% above the cutoff for both the 500 ng/mL and 1000 ng/mL cutoffs in qualitative and semi quantitative modes. Each sample was run 20 times in one day. The results are summarized below.
## Qualitative Summary
| Analyte | Sample Concentration (ng/mL) | N | 500 Cutoff #Neg/#Pos | 1000 Cutoff #Neg/#Pos |
| --- | --- | --- | --- | --- |
| Amphetamine | 150 | 20 | 20/0 | 20/0 |
| | 375 | 20 | 20/0 | 20/0 |
| | 500 | 20 | 10/10 | 20/0 |
| | 625 | 20 | 0/20 | 20/0 |
| | 750 | 20 | 0/20 | 20/0 |
| | 1000 | 20 | 0/20 | 11/9 |
| | 1250 | 20 | 0/20 | 0/20 |
| | 1500 | 20 | 0/20 | 0/20 |
| Methamphetamine | 150 | 20 | 20/0 | 20/0 |
| | 375 | 20 | 20/0 | 20/0 |
| | 500 | 20 | 10/10 | 20/0 |
| | 625 | 20 | 0/20 | 20/0 |
| | 750 | 20 | 0/20 | 20/0 |
| | 1000 | 20 | 0/20 | 10/10 |
| | 1250 | 20 | 0/20 | 0/20 |
| | 1500 | 20 | 0/20 | 0/20 |
## Amphetamine, semi-quantitative
| Level | 150 ng/mL | 375 ng/mL | 500 ng/mL | 625 ng/mL | 750 ng/mL | 1000 ng/mL | 1250 ng/mL | 1500 ng/mL |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Mean (ng/mL) | 152.2 | 383.3 | 491.6 | 615.1 | 801.0 | 997.6 | 1373.2 | 1476.3 |
| SD | 6.7 | 6.4 | 9.7 | 13.1 | 13.8 | 13.7 | 22.6 | 16.2 |
| %CV | 4.4 | 1.7 | 2.0 | 2.1 | 1.7 | 1.4 | 1.6 | 1.1 |
| Recovery | 101% | 102% | 98% | 98% | 107% | 100% | 110% | 98% |
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| GC/MS (ng/mL) | 130 | 369 | 493 | 605 | 756 | 923 | 1293 | 1546 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
Methamphetamine, semi-quantitative
| Level | 150 ng/mL | 375 ng/mL | 500 ng/mL | 625 ng/mL | 750 ng/mL | 1000 ng/mL | 1250 ng/mL | 1500 ng/mL |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Mean (ng/mL) | 168.5 | 408.2 | 523.5 | 639.9 | 784.9 | 1057.4 | 1314.3 | 1541.3 |
| SD | 6.1 | 7.2 | 4.1 | 7.7 | 8.5 | 11.7 | 13.5 | 18.3 |
| %CV | 3.6 | 1.8 | 0.8 | 1.2 | 1.1 | 1.1 | 1 | 1.2 |
| Recovery | 112 | 109 | 105 | 102 | 105 | 106 | 105 | 103 |
| GC/MS (ng/mL) | 140 | 371 | 498 | 608 | 771 | 1008 | 1350 | 1414 |
b. Linearity/assay reportable range:
Drug free urine was spiked to 2000 ng/mL with methamphetamine, then diluted in 10% increments with drug free urine and analyzed using the semi-quantitative DRI Amphetamines assay. The measured results were within ±4% of the expected values for all concentrations tested. A linear regression calculation was performed and resulted in a slope of 0.984, a y-intercept of 13.87 ng/mL, and a correlation coefficient of 0.999. The results are summarized below.
| Dilution (%) | Mean (ng/ml) | Expected (ng/ml) | % Recovery |
| --- | --- | --- | --- |
| 0% | 0.0 | 0.0 | N/A |
| 10 % | 203.6 | 197.2 | 103.2 |
| 20% | 400.8 | 394.5 | 101.6 |
| 30% | 614.6 | 591.7 | 103.9 |
| 40% | 811.8 | 789.0 | 102.9 |
| 50% | 986.0 | 986.2 | 100.0 |
| 60% | 1180.0 | 1183.4 | 99.7 |
| 70% | 1353.4 | 1380.7 | 98.0 |
| 80% | 1551.8 | 1577.9 | 98.3 |
| 90 % | 1748.6 | 1775.2 | 98.5 |
| 100 % | 1972.4 | 1972.4 | 100.0 |
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The assay is calibrated to methamphetamine and five level calibrators were cleared under 510(k) number k983159. All calibrators can be used to generate a semi-quantitative result, or either the 500 ng/mL or 1000 ng/mL calibrator
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can be used as qualitative cutoff reference for distinguishing positive from negative samples.
Controls were previously cleared under 510(k) number k040758.
The sponsor provided the stability study protocols for reagent stability studies conducted at 2-8°C. On-board stability studies demonstrated that the reagents are stable for 60 days when stored on the analyzer as claimed in the package insert.
d. Detection limit:
Performance at low drug concentrations in the semi-quantitative assay was characterized by determination of recovery (see section b above).
e. Analytical specificity:
Cross reactivity was evaluated by spiking compounds into drug free urine and tested in the qualitative and semi quantitative assays. The compounds, concentrations tested, and results are summarized below.
The following compounds produced a positive result at the concentrations shown in the table.
500 cutoff
| Compound | Concentration tested (ng/mL) | Semi-quantitative (ng/mL) | Qualitative Negative/Positive |
| --- | --- | --- | --- |
| d-Amphetamine | 500 | 521 | Positive |
| d-Methamphetamine | 500 | 504 | Positive |
| Methylenedioxy-amphetamine (MDA) | 1400 | 502 | Positive |
| Methylenedioxy-methamphetamine(MDMA) | 800 | 537 | Positive |
1000 cutoff
| Compound | Concentration tested (ng/mL) | Semi-quantitative (ng/mL) | Qualitative Negative/Positive |
| --- | --- | --- | --- |
| d-Amphetamine | 1000 | 1048 | Positive |
| d-Methamphetamine | 1000 | 1098 | Positive |
| Methylenedioxy-amphetamine (MDA) | 2500 | 1051 | Positive |
| Methylenedioxy-methamphetamine (MDMA) | 1300 | 1046 | Positive |
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| Compound | 500 Cutoff Concentration (ng/mL) | 1000 Cutoff Concentration (ng/mL) |
| --- | --- | --- |
| Acetaminophen | 1000000 | 1000000 |
| Acetylsalicylic Acid | 1000000 | 1000000 |
| l-Amphetamine | 12500 | 12500 |
| Benzoylecgonine | 1000000 | 1000000 |
| Benzphetamine | 20000 | 20000 |
| Benzylpiperazine | 40000 | 63000 |
| Bupropion | 13000 | 50000 |
| Caffeine | 1000000 | 1000000 |
| Cetirizin | | |
| Dihydrochloride | 1000000 | 1000000 |
| Chlorpromazine | 500000 | 500000 |
| Codeine | 1000000 | 1000000 |
| Dextromethorphan | 1000000 | 1000000 |
| d-Ephedrine | 1000000 | 2000000 |
| l-Ephedrine | 100000 | 350000 |
| d,l-Ephedrine | 200000 | 700000 |
| Fenfluramine | 1200 | 4000 |
| Isometheptene | 6000 | 20000 |
| Isoxsuprine | 100000 | 100000 |
| Meperidine | 1000000 | 1000000 |
| Mephentermine | 15000 | 25000 |
| Methadone | 1000000 | 1000000 |
| II-Methamphetamine | 3500 | 10000 |
| Methapyrilene | 100000 | 500000 |
| Methylphenidate | 150000 | 500000 |
| Metronidazole | 1000000 | 1000000 |
| Morphine | 1000000 | 1000000 |
| Norpseudoephedrine | 600000 | 1000000 |
| Oxazepam | 500000 | 500000 |
| Phencyclidine | 1000000 | 1000000 |
| Phendimetrazine | 40000 | 200000 |
| Phenethylamine | 30000 | 100000 |
| Phenmetrazine | 1500 | 4000 |
| Phenobarbital | 1000000 | 1000000 |
| Phenothiazine | 10000 | 10000 |
| Phentermine | 17500 | 25000 |
| Phenylephrine | 300000 | 500000 |
| Phenylpropanolamine | 200000 | 250000 |
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To evaluate interference the sponsor spiked potentially interfering compounds into low and high amphetamine and methamphetamine controls for the 500 ng/mL and 1000 ng/mL cutoffs. The compounds and concentrations listed in the table below were found not to interfere for the qualitative assays and the semi-quantitative assay.
## 500 cutoff – 375 ng/mL Amphetamine control
| Interference Compound | Concentration | Qualitative | Semi-quantitative (ng/mL) | Semi-quantitative % Recovery |
| --- | --- | --- | --- | --- |
| Low Control | 375 ng/mL | Negative | 358.5 | 96% |
| Acetaminophen | 100 ug/mL | Negative | 358.5 | 96% |
| Acetone | 1 g/dL | Negative | 361.5 | 96% |
| Ascorbic acid | 1 g/dL | Negative | 339 | 90% |
| Aspirin | 100 ug/mL | Negative | 352.5 | 94% |
| Caffeine | 100 ug/mL | Negative | 362.5 | 97% |
| Creatinine | 500 mg/dL | Negative | 416 | 111% |
| Ethanol | 1 g/dL | Negative | 356 | 95% |
| Galactose | 10 mg/dL | Negative | 360 | 93% |
| Y -Globulin | 500 mg/dL | Negative | 349 | 95% |
| Glucose | 3 g/dL | Negative | 356.5 | 96% |
| Hemoglobin | 150 mg/dL | Negative | 377.5 | 101% |
| Human serum albumin | 500 mg/dL | Negative | 367.5 | 98% |
| Ibuprofen | 100 I.lg/mL | Negative | 352 | 94% |
| Oxalic acid | 100 mg/dL | Negative | 347.5 | 93% |
| Riboflavin | 7.5 mg/dL | Negative | 345 | 92% |
| Sodium | 1 g/dL | Negative | 346 | 92% |
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| chloride | | | | |
| --- | --- | --- | --- | --- |
| Urea | 1.25 g/dL | Negative | 352 | 94% |
| pH | 3 | Negative | 350 | 93% |
| pH | 4 | Negative | 359.5 | 96% |
| pH | 5 | Negative | 356.5 | 95% |
| pH | 6 | Negative | 360 | 96% |
| pH | 7 | Negative | 353.5 | 94% |
| pH | 8 | Negative | 349 | 93% |
| pH | 9 | Negative | 365.5 | 97% |
| pH | 10 | Negative | 350.5 | 93% |
| pH | 11 | Negative | 357 | 95% |
| Specific Gravity | 1.004 g/mL | Negative | 340 | 91% |
| Specific Gravity | 1.007 g/mL | Negative | 357.5 | 95% |
| Specific Gravity | 1.011 g/mL | Negative | 346.5 | 92% |
| Specific Gravity | 1.014 g/mL | Negative | 350.5 | 93% |
| Specific Gravity | 1.017 g/mL | Negative | 357 | 95% |
| Specific Gravity | 1.022 g/mL | Negative | 364 | 97% |
| Specific Gravity | 1.026 g/mL | Negative | 366.5 | 98% |
| Specific Gravity | 1.030 g/mL | Negative | 367.5 | 98% |
| Specific Gravity | 1.034 g/mL | Negative | 373 | 99% |
| Specific Gravity | 1.038 g/mL | Negative | 378 | 101% |
500 cutoff – 625 ng/mL Amphetamine control
| Interference Compound | Concentration | Qualitative | Semi-quantitative (ng/mL) | Semi-quantitative % Recovery |
| --- | --- | --- | --- | --- |
| High Control | 625 ng/mL | Positive | 646.5 | 103% |
| Acetaminophen | 100 ug/mL | Positive | 669.0 | 107% |
| Acetone | 1 g/dL | Positive | 660.0 | 106% |
| Ascorbic acid | 1 g/dL | Positive | 624.0 | 100% |
| Aspirin | 100 ug/mL | Positive | 656.5 | 105% |
| Caffeine | 100 ug/mL | Positive | 659.5 | 106% |
| Creatinine | 500 mg/dL | Positive | 683.0 | 109% |
| Ethanol | 1 g/dL | Positive | 653.5 | 105% |
| Galactose | 10 mg/dL | Positive | 648.5 | 104% |
| Y -Globulin | 500 mg/dL | Positive | 654.0 | 105% |
| Glucose | 3 g/dL | Positive | 645.0 | 103% |
| Hemoglobin | 150 mg/dL | Positive | 661.0 | 106% |
| Human serum albumin | 500 mg/dL | Positive | 652.5 | 104% |
| Ibuprofen | 100 I.lg/mL | Positive | 650.0 | 104% |
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| Oxalic acid | 100 mg/dL | Positive | 638.0 | 102% |
| --- | --- | --- | --- | --- |
| Riboflavin | 7.5 mg/dL | Positive | 639.0 | 102% |
| Sodium chloride | 1 g/dL | Positive | 645.5 | 103% |
| Urea | 1.25 g/dL | Positive | 643.0 | 103% |
| pH | 3 | Positive | 634.0 | 101% |
| pH | 4 | Positive | 635.0 | 102% |
| pH | 5 | Positive | 618.0 | 99% |
| pH | 6 | Positive | 648.5 | 104% |
| pH | 7 | Positive | 637.0 | 102% |
| pH | 8 | Positive | 635.5 | 102% |
| pH | 9 | Positive | 639.0 | 102% |
| pH | 10 | Positive | 648.0 | 104% |
| pH | 11 | Positive | 641.0 | 103% |
| Specific Gravity | 1.004 g/mL | Positive | 625.0 | 100% |
| Specific Gravity | 1.007 g/mL | Positive | 641.0 | 103% |
| Specific Gravity | 1.011 g/mL | Positive | 639.5 | 102% |
| Specific Gravity | 1.014 g/mL | Positive | 641.5 | 103% |
| Specific Gravity | 1.017 g/mL | Positive | 642.0 | 103% |
| Specific Gravity | 1.022 g/mL | Positive | 649.5 | 104% |
| Specific Gravity | 1.026 g/mL | Positive | 665.5 | 106% |
| Specific Gravity | 1.030 g/mL | Positive | 659.0 | 105% |
| Specific Gravity | 1.034 g/mL | Positive | 655.5 | 105% |
| Specific Gravity | 1.038 g/mL | Positive | 656.5 | 105% |
## 1000 cutoff – 750 ng/mL Amphetamine control
| Interference Compound | Concentration | Qualitative | Semi-quantitative (ng/mL) | Semi-quantitative % Recovery |
| --- | --- | --- | --- | --- |
| Low Control | 750 ng/mL | Negative | 755.5 | 101% |
| Acetaminophen | 100 ug/mL | Negative | 761.5 | 102% |
| Acetone | 1 g/dL | Negative | 748.5 | 100% |
| Ascorbic acid | 1 g/dL | Negative | 724.0 | 97% |
| Aspirin | 100 ug/mL | Negative | 757.5 | 101% |
| Caffeine | 100 ug/mL | Negative | 758.0 | 101% |
| Creatinine | 500 mg/dL | Negative | 797.0 | 106% |
| Ethanol | 1 g/dL | Negative | 759.0 | 101% |
| Galactose | 10 mg/dL | Negative | 759.5 | 101% |
| Y -Globulin | 500 mg/dL | Negative | 761.0 | 101% |
| Glucose | 3 g/dL | Negative | 757.5 | 101% |
| Hemoglobin | 150 mg/dL | Negative | 790.0 | 105% |
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| Human serum albumin | 500 mg/dL | Negative | 775.5 | 103% |
| --- | --- | --- | --- | --- |
| Ibuprofen | 100 I.lg/mL | Negative | 753.0 | 100% |
| Oxalic acid | 100 mg/dL | Negative | 756.5 | 101% |
| Riboflavin | 7.5 mg/dL | Negative | 746.0 | 99% |
| Sodium chloride | 1 g/dL | Negative | 741.0 | 99% |
| Urea | 1.25 g/dL | Negative | 754.0 | 101% |
| pH | 3 | Negative | 737.5 | 98% |
| pH | 4 | Negative | 737.0 | 98% |
| pH | 5 | Negative | 752.5 | 100% |
| pH | 6 | Negative | 761.5 | 102% |
| pH | 7 | Negative | 756.5 | 101% |
| pH | 8 | Negative | 781.5 | 104% |
| pH | 9 | Negative | 777.5 | 104% |
| pH | 10 | Negative | 780.0 | 104% |
| pH | 11 | Negative | 786.0 | 105% |
| Specific Gravity | 1.004 g/mL | Negative | 756.0 | 101% |
| Specific Gravity | 1.007 g/mL | Negative | 754.0 | 101% |
| Specific Gravity | 1.011 g/mL | Negative | 757.5 | 101% |
| Specific Gravity | 1.014 g/mL | Negative | 789.5 | 105% |
| Specific Gravity | 1.017 g/mL | Negative | 772.0 | 103% |
| Specific Gravity | 1.022 g/mL | Negative | 765.0 | 102% |
| Specific Gravity | 1.026 g/mL | Negative | 771.5 | 103% |
| Specific Gravity | 1.030 g/mL | Negative | 803.0 | 107% |
| Specific Gravity | 1.034 g/mL | Negative | 789.0 | 105% |
| Specific Gravity | 1.038 g/mL | Negative | 788.5 | 105% |
1000 cutoff - 1250 ng/mL Amphetamine control
| Interference Compound | Concentration | Qualitative | Semi-quantitative (ng/mL) | Semi-quantitative % Recovery |
| --- | --- | --- | --- | --- |
| High Control | 1250 ng/mL | Positive | 1291.0 | 103% |
| Acetaminophen | 100 ug/mL | Positive | 1298.0 | 104% |
| Acetone | 1 g/dL | Positive | 1312.0 | 105% |
| Ascorbic acid | 1 g/dL | Positive | 1212.0 | 97% |
| Aspirin | 100 ug/mL | Positive | 1275.5 | 102% |
| Caffeine | 100 ug/mL | Positive | 1320.5 | 106% |
| Creatinine | 500 mg/dL | Positive | 1376.0 | 110% |
| Ethanol | 1 g/dL | Positive | 1288.0 | 103% |
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| Galactose | 10 mg/dL | Positive | 1283.5 | 103% |
| --- | --- | --- | --- | --- |
| Y -Globulin | 500 mg/dL | Positive | 1305.0 | 104% |
| Glucose | 3 g/dL | Positive | 1296.0 | 104% |
| Hemoglobin | 150 mg/dL | Positive | 1268.5 | 101% |
| Human serum albumin | 500 mg/dL | Positive | 1285.0 | 103% |
| Ibuprofen | 100 I./g/mL | Positive | 1294.0 | 104% |
| Oxalic acid | 100 mg/dL | Positive | 1289.5 | 103% |
| Riboflavin | 7.5 mg/dL | Positive | 1288.5 | 103% |
| Sodium chloride | 1 g/dL | Positive | 1275.5 | 102% |
| Urea | 1.25 g/dL | Positive | 1295.5 | 104% |
| pH | 3 | Positive | 1238.0 | 99% |
| pH | 4 | Positive | 1261.0 | 101% |
| pH | 5 | Positive | 1258.5 | 101% |
| pH | 6 | Positive | 1291.0 | 103% |
| pH | 7 | Positive | 1273.5 | 102% |
| pH | 8 | Positive | 1283.0 | 103% |
| pH | 9 | Positive | 1283.0 | 103% |
| pH | 10 | Positive | 1281.0 | 102% |
| pH | 11 | Positive | 1276.0 | 102% |
| Specific Gravity | 1.004 g/mL | Positive | 1262.0 | 101% |
| Specific Gravity | 1.007 g/mL | Positive | 1267.5 | 101% |
| Specific Gravity | 1.011 g/mL | Positive | 1292.5 | 103% |
| Specific Gravity | 1.014 g/mL | Positive | 1287.0 | 103% |
| Specific Gravity | 1.017 g/mL | Positive | 1281.5 | 103% |
| Specific Gravity | 1.022 g/mL | Positive | 1309.0 | 105% |
| Specific Gravity | 1.026 g/mL | Positive | 1301.5 | 104% |
| Specific Gravity | 1.030 g/mL | Positive | 1304.0 | 104% |
| Specific Gravity | 1.034 g/mL | Positive | 1300.5 | 104% |
| Specific Gravity | 1.038 g/mL | Positive | 1239.0 | 111% |
500 cutoff – 375 ng/mL Methamphetamine control
| Interference Compound | Concentration | Qualitative | Semi-quantitative (ng/mL) | Semi-quantitative % Recovery |
| --- | --- | --- | --- | --- |
| Low Control | 375 ng/mL | 353.0 | Negative | 94% |
| Acetaminophen | 100 ug/mL | 359.5 | Negative | 96% |
| Acetone | 1 g/dL | 355.0 | Negative | 95% |
| Ascorbic acid | 1 g/dL | 359.0 | Negative | 96% |
| Aspirin | 100 ug/mL | 344.5 | Negative | 92% |
{13}
| Caffeine | 100 ug/mL | 366.5 | Negative | 98% |
| --- | --- | --- | --- | --- |
| Creatinine | 500 mg/dL | 405.0 | Negative | 108% |
| Ethanol | 1 g/dL | 353.5 | Negative | 94% |
| Galactose | 10 mg/dL | 357.5 | Negative | 95% |
| Y -Globulin | 500 mg/dL | 367.0 | Negative | 98% |
| Glucose | 3 g/dL | 359.5 | Negative | 96% |
| Hemoglobin | 150 mg/dL | 375.0 | Negative | 100% |
| Human serum albumin | 500 mg/dL | 361.5 | Negative | 96% |
| Ibuprofen | 100 L.lg/mL | 353.5 | Negative | 94% |
| Oxalic acid | 100 mg/dL | 361.5 | Negative | 96% |
| Riboflavin | 7.5 mg/dL | 357.0 | Negative | 95% |
| Sodium chloride | 1 g/dL | 361.5 | Negative | 96% |
| Urea | 1.25 g/dL | 356.0 | Negative | 95% |
| pH | 3 | 373.5 | Negative | 100% |
| pH | 4 | 370.0 | Negative | 99% |
| pH | 5 | 384.0 | Negative | 102% |
| pH | 6 | 366.0 | Negative | 98% |
| pH | 7 | 384.0 | Negative | 102% |
| pH | 8 | 378.5 | Negative | 101% |
| pH | 9 | 374.0 | Negative | 100% |
| pH | 10 | 380.5 | Negative | 101% |
| pH | 11 | 374.0 | Negative | 100% |
| Specific Gravity | 1.004 g/mL | 366.5 | Negative | 98% |
| Specific Gravity | 1.007 g/mL | 375.5 | Negative | 100% |
| Specific Gravity | 1.011 g/mL | 371.0 | Negative | 99% |
| Specific Gravity | 1.014 g/mL | 367.5 | Negative | 98% |
| Specific Gravity | 1.017 g/mL | 373.0 | Negative | 99% |
| Specific Gravity | 1.022 g/mL | 399.5 | Negative | 107% |
| Specific Gravity | 1.026 g/mL | 375.0 | Negative | 100% |
| Specific Gravity | 1.030 g/mL | 375.5 | Negative | 100% |
| Specific Gravity | 1.034 g/mL | 382.0 | Negative | 102% |
| Specific Gravity | 1.038 g/mL | 379.0 | Negative | 101% |
500 cutoff - 625 ng/mL Methamphetamine control
| Interference Compound | Concentration | Qualitative | Semi-quantitative (ng/mL) | Semi-quantitative % Recovery |
| --- | --- | --- | --- | --- |
| High Control | 625 ng/mL | Positive | 619.0 | 99% |
| Acetaminophen | 100 ug/mL | Positive | 635.0 | 102% |
{14}
| Acetone | 1 g/dL | Positive | 632.5 | 101% |
| --- | --- | --- | --- | --- |
| Ascorbic acid | 1 g/dL | Positive | 625.0 | 100% |
| Aspirin | 100 ug/mL | Positive | 613.0 | 98% |
| Caffeine | 100 ug/mL | Positive | 632.5 | 101% |
| Creatinine | 500 mg/dL | Positive | 651.0 | 104% |
| Ethanol | 1 g/dL | Positive | 630.5 | 101% |
| Galactose | 10 mg/dL | Positive | 628.5 | 101% |
| Y -Globulin | 500 mg/dL | Positive | 617.0 | 99% |
| Glucose | 3 g/dL | Positive | 620.0 | 99% |
| Hemoglobin | 150 mg/dL | Positive | 640.0 | 102% |
| Human serum albumin | 500 mg/dL | Positive | 625.0 | 100% |
| Ibuprofen | 100 L.lg/mL | Positive | 607.0 | 97% |
| Oxalic acid | 100 mg/dL | Positive | 619.5 | 99% |
| Riboflavin | 7.5 mg/dL | Positive | 638.0 | 102% |
| Sodium chloride | 1 g/dL | Positive | 615.0 | 98% |
| Urea | 1.25 g/dL | Positive | 638.0 | 102% |
| pH | 3 | Positive | 656.0 | 105% |
| pH | 4 | Positive | 646.0 | 103% |
| pH | 5 | Positive | 646.5 | 103% |
| pH | 6 | Positive | 631.0 | 101% |
| pH | 7 | Positive | 646.5 | 103% |
| pH | 8 | Positive | 644.0 | 103% |
| pH | 9 | Positive | 639.5 | 102% |
| pH | 10 | Positive | 639.5 | 102% |
| pH | 11 | Positive | 625.5 | 100% |
| Specific Gravity | 1.004 g/mL | Positive | 630.5 | 101% |
| Specific Gravity | 1.007 g/mL | Positive | 629.5 | 101% |
| Specific Gravity | 1.011 g/mL | Positive | 637.0 | 102% |
| Specific Gravity | 1.014 g/mL | Positive | 623.5 | 100% |
| Specific Gravity | 1.017 g/mL | Positive | 634.0 | 101% |
| Specific Gravity | 1.022 g/mL | Positive | 634.5 | 102% |
| Specific Gravity | 1.026 g/mL | Positive | 657.0 | 105% |
| Specific Gravity | 1.030 g/mL | Positive | 646.0 | 103% |
| Specific Gravity | 1.034 g/mL | Positive | 652.0 | 104% |
| Specific Gravity | 1.038 g/mL | Positive | 661.5 | 106% |
1000 cutoff - 750 ng/mL Methamphetamine control
{15}
| Interference Compound | Concentration | Qualitative | Semi-quantitative (ng/mL) | Semi-quantitative % Recovery |
| --- | --- | --- | --- | --- |
| Low Control | 750 ng/mL | Negative | 769.0 | 102% |
| Acetaminophen | 100 ug/mL | Negative | 764.0 | 102% |
| Acetone | 1 g/dL | Negative | 752.0 | 100% |
| Ascorbic acid | 1 g/dL | Negative | 764.5 | 102% |
| Aspirin | 100 ug/mL | Negative | 765.0 | 102% |
| Caffeine | 100 ug/mL | Negative | 776.0 | 103% |
| Creatinine | 500 mg/dL | Negative | 777.5 | 104% |
| Ethanol | 1 g/dL | Negative | 751.5 | 100% |
| Galactose | 10 mg/dL | Negative | 770.5 | 103% |
| Y -Globulin | 500 mg/dL | Negative | 766.5 | 102% |
| Glucose | 3 g/dL | Negative | 762.0 | 102% |
| Hemoglobin | 150 mg/dL | Negative | 769.0 | 103% |
| Human serum albumin | 500 mg/dL | Negative | 787.5 | 105% |
| Ibuprofen | 100 I.lg/mL | Negative | 773.0 | 103% |
| Oxalic acid | 100 mg/dL | Negative | 771.5 | 103% |
| Riboflavin | 7.5 mg/dL | Negative | 757.5 | 101% |
| Sodium chloride | 1 g/dL | Negative | 773.5 | 103% |
| Urea | 1.25 g/dL | Negative | 767.0 | 102% |
| pH | 3 | Negative | 780.5 | 104% |
| pH | 4 | Negative | 782.5 | 104% |
| pH | 5 | Negative | 784.5 | 105% |
| pH | 6 | Negative | 777.0 | 104% |
| pH | 7 | Negative | 778.5 | 104% |
| pH | 8 | Negative | 782.0 | 104% |
| pH | 9 | Negative | 785.0 | 105% |
| pH | 10 | Negative | 778.0 | 104% |
| pH | 11 | Negative | 784.0 | 105% |
| Specific Gravity | 1.004 g/mL | Negative | 752.0 | 100% |
| Specific Gravity | 1.007 g/mL | Negative | 768.5 | 102% |
| Specific Gravity | 1.011 g/mL | Negative | 764.0 | 102% |
| Specific Gravity | 1.014 g/mL | Negative | 769.5 | 103% |
| Specific Gravity | 1.017 g/mL | Negative | 738.5 | 98% |
| Specific Gravity | 1.022 g/mL | Negative | 759.0 | 101% |
| Specific Gravity | 1.026 g/mL | Negative | 745.5 | 99% |
| Specific Gravity | 1.030 g/mL | Negative | 782.0 | 104% |
| Specific Gravity | 1.034 g/mL | Negative | 752.5 | 100% |
{16}
Specific Gravity
1.038 g/mL
Negative
748.5
100%
1000 cutoff – 1250 ng/mL Methamphetamine control
| Interference Compound | Concentration | Qualitative | Semi-quantitative (ng/mL) | Semi-quantitative % Recovery |
| --- | --- | --- | --- | --- |
| High Control | 1250 ng/mL | Positive | 1219.0 | 98% |
| Acetaminophen | 100 ug/mL | Positive | 1267.5 | 101% |
| Acetone | 1 g/dL | Positive | 1223.0 | 98% |
| Ascorbic acid | 1 g/dL | Positive | 1197.0 | 96% |
| Aspirin | 100 ug/mL | Positive | 1245.0 | 100% |
| Caffeine | 100 ug/mL | Positive | 1262.5 | 101% |
| Creatinine | 500 mg/dL | Positive | 1276.5 | 102% |
| Ethanol | 1 g/dL | Positive | 1226.5 | 98% |
| Galactose | 10 mg/dL | Positive | 1245.0 | 100% |
| Y -Globulin | 500 mg/dL | Positive | 1233.5 | 99% |
| Glucose | 3 g/dL | Positive | 1249.0 | 100% |
| Hemoglobin | 150 mg/dL | Positive | 1281.0 | 102% |
| Human serum albumin | 500 mg/dL | Positive | 1232.5 | 99% |
| Ibuprofen | 100 I.lg/mL | Positive | 1201.0 | 96% |
| Oxalic acid | 100 mg/dL | Positive | 1238.0 | 99% |
| Riboflavin | 7.5 mg/dL | Positive | 1269.5 | 102% |
| Sodium chloride | 1 g/dL | Positive | 1247.0 | 100% |
| Urea | 1.25 g/dL | Positive | 1228.0 | 98% |
| pH | 3 | Positive | 1274.5 | 102% |
| pH | 4 | Positive | 1250.5 | 100% |
| pH | 5 | Positive | 1247.5 | 100% |
| pH | 6 | Positive | 1237.5 | 99% |
| pH | 7 | Positive | 1252.0 | 100% |
| pH | 8 | Positive | 1255.0 | 100% |
| pH | 9 | Positive | 1244.5 | 100% |
| pH | 10 | Positive | 1256.0 | 100% |
| pH | 11 | Positive | 1261.0 | 101% |
| Specific Gravity | 1.004 g/mL | Positive | 1269.5 | 102% |
| Specific Gravity | 1.007 g/mL | Positive | 1260.5 | 101% |
| Specific Gravity | 1.011 g/mL | Positive | 1281.5 | 103% |
| Specific Gravity | 1.014 g/mL | Positive | 1242.5 | 99% |
| Specific Gravity | 1.017 g/mL | Positive | 1263.0 | 101% |
| Specific Gravity | 1.022 g/mL | Positive | 1271.0 | 102% |
17
{17}
18
| Specific Gravity | 1.026 g/mL | Positive | 1283.5 | 103% |
| --- | --- | --- | --- | --- |
| Specific Gravity | 1.030 g/mL | Positive | 1306.5 | 105% |
| Specific Gravity | 1.034 g/mL | Positive | 1259.5 | 101% |
| Specific Gravity | 1.038 g/mL | Positive | 1305.5 | 104% |
f. Assay cut-off:
There are two cutoff concentrations claimed for both amphetamine and methamphetamine: 500 ng/mL and 1000 ng/mL.
2. Comparison studies:
a. Method comparison with predicate device:
The sponsor conducted a method comparison study to evaluate the performance of the device for d-amphetamine and d-methamphetamine. The DRI amphetamines assay recognizes both amphetamine and methamphetamine equivalently and does not discriminate between the two drugs. This study evaluated 160 unaltered clinical samples by the DRI amphetamines assay and compared the results separately to GC/MS results for amphetamine and methamphetamine. The agreement between amphetamine GC/MS results and methamphetamine GC/MS results and the new device results for both qualitative and semi-quantitative modes of the device are listed in the tables below.
Qualitative (Total Samples) - 500 Cutoff (DRI vs. AMP GC/MS)
| New Device (DRI) | Low negative by GC/MS (less than -50%) | Near cutoff negative by GC/MS (between -50% and cutoff) | Near cutoff positive by GC/MS (between cutoff and +50%) | High positive by GC/MS (greater than +50%) | Percent Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Positive | 34 | 24 | 14 | 49 | 100.0% |
| Negative | 16 | 1 | 0 | 0 | 22.4% |
| | Negative GC/MS | Positive GC/MS | Total |
| --- | --- | --- | --- |
| Negative New device (DRI) | 17 | 0 | 17 |
{18}
| Positive New device (DRI) | 58 | 63 | 121 |
| --- | --- | --- | --- |
| Total | 75 | 63 | 138 |
# Discordant Samples
The method comparison samples were categorized based upon the d-amphetamine GC/MS concentration only. The table below identifies those samples with a d-amphetamine GC/MS concentration below the cutoff, in which the observed result on the DRI amphetamines assay was positive.
| Cutoff Value (ng/mL) | Sample # | GC/MS -Amph (ng/mL) | GC/MS -Meth (ng/mL) | GC/MS -Total (ng/mL) | DRI (Neg/Pos) |
| --- | --- | --- | --- | --- | --- |
| 500 | 2 | 47 | 1653 | 1700 | Pos |
| 500 | 9 | 68 | 1621 | 1689 | Pos |
| 500 | 10 | 68 | 334 | 402 | Pos |
| 500 | 11 | 69 | 1666 | 1735 | Pos |
| 500 | 12 | 69 | 1707 | 1776 | Pos |
| 500 | 13 | 70 | 444 | 514 | Pos |
| 500 | 14 | 70 | 1513 | 1583 | Pos |
| 500 | 15 | 76 | 1679 | 1755 | Pos |
| 500 | 16 | 82 | 533 | 615 | Pos |
| 500 | 17 | 83 | 481 | 564 | Pos |
| 500 | 21 | 100 | 538 | 638 | Pos |
| 500 | 22 | 100 | 675 | 775 | Pos |
| 500 | 23 | 109 | 1446 | 1555 | Pos |
| 500 | 26 | 123 | 661 | 784 | Pos |
| 500 | 27 | 128 | 503 | 631 | Pos |
| 500 | 28 | 128 | 1221 | 1349 | Pos |
| 500 | 29 | 141 | 1259 | 1400 | Pos |
| 500 | 30 | 148 | 942 | 1090 | Pos |
| 500 | 32 | 160 | 1254 | 1414 | Pos |
| 500 | 33 | 161 | 1415 | 1576 | Pos |
| 500 | 34 | 168 | 1319 | 1487 | Pos |
| 500 | 35 | 168 | 1595 | 1763 | Pos |
| 500 | 37 | 184 | 548 | 732 | Pos |
| 500 | 39 | 189 | 1067 | 1256 | Pos |
| 500 | 40 | 200 | 1024 | 1224 | Pos |
| 500 | 41 | 202 | 393 | 595 | Pos |
{19}
| 500 | 43 | 203 | 1230 | 1433 | Pos |
| --- | --- | --- | --- | --- | --- |
| 500 | 44 | 211 | 1421 | 1632 | Pos |
| 500 | 45 | 212 | 1241 | 1453 | Pos |
| 500 | 46 | 214 | 97 | 311 | Pos |
| 500 | 47 | 231 | 1782 | 2013 | Pos |
| 500 | 48 | 232 | 207 | 439 | Pos |
| 500 | 49 | 240 | 449 | 689 | Pos |
| 500 | 50 | 246 | 460 | 706 | Pos |
| 500 | 51 | 258 | 1029 | 1287 | Pos |
| 500 | 52 | 264 | 1642 | 1906 | Pos |
| 500 | 53 | 270 | 479 | 749 | Pos |
| 500 | 54 | 271 | 1338 | 1609 | Pos |
| 500 | 55 | 272 | 1080 | 1352 | Pos |
| 500 | 56 | 273 | 516 | 789 | Pos |
| 500 | 57 | 298 | 2772 | 3070 | Pos |
| 500 | 58 | 300 | 101 | 401 | Pos |
| 500 | 59 | 307 | 2411 | 2718 | Pos |
| 500 | 60 | 317 | 2668 | 2985 | Pos |
| 500 | 61 | 325 | 2828 | 3153 | Pos |
| 500 | 62 | 330 | 2543 | 2873 | Pos |
| 500 | 63 | 374 | 693 | 1067 | Pos |
| 500 | 64 | 380 | 709 | 1089 | Pos |
| 500 | 65 | 402 | 132 | 534 | Pos |
| 500 | 66 | 407 | 747 | 1154 | Pos |
| 500 | 67 | 417 | 1088 | 1505 | Pos |
| 500 | 68 | 426 | 1599 | 2025 | Pos |
| 500 | 69 | 450 | 828 | 1278 | Pos |
| 500 | 71 | 486 | 860 | 1346 | Pos |
| 500 | 72 | 490 | 1287 | 1777 | Pos |
| 500 | 73 | 493 | 1005 | 1498 | Pos |
| 500 | 74 | 494 | 924 | 1418 | Pos |
| 500 | 75 | 498 | 919 | 1417 | Pos |
Semi-Quantitative (Total Samples) - 500 Cutoff (DRI vs. AMP GC/MS)
{20}
| New Device (DRI) | Low negative by GC/MS (less than -50%) | Near cutoff negative by GC/MS (between -50% and cutoff) | Near cutoff positive by GC/MS (between cutoff and +50%) | High positive by GC/MS (greater than +50%) | Percent Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Positive | 34 | 24 | 14 | 49 | 100.0% |
| Negative | 16 | 1 | 0 | 0 | 22.7% |
| | Negative GC/MS | Positive GC/MS | Total |
| --- | --- | --- | --- |
| Negative New device (DRI) | 17 | 0 | 17 |
| Positive New device (DRI) | 58 | 63 | 121 |
| Total | 75 | 63 | 138 |
# Discordant Samples
The method comparison samples were categorized based upon the d-amphetamine GC/MS concentration only. The table below identifies those samples with a d-amphetamine GC/MS concentration below the cutoff, in which the observed result on the DRI amphetamines assay was positive.
| Cutoff Value (ng/mL) | Sample # | GC/MS -Amph (ng/mL) | GC/MS -Meth (ng/mL) | GC/MS -Total (ng/mL) | DRI (Neg/Pos) |
| --- | --- | --- | --- | --- | --- |
| 500 | 2 | 47 | 1653 | 1700 | 1661 |
| 500 | 9 | 68 | 1621 | 1689 | 1709 |
| 500 | 10 | 68 | 334 | 402 | 1462 |
| 500 | 11 | 69 | 1666 | 1735 | 1731 |
| 500 | 12 | 69 | 1707 | 1776 | 1711 |
| 500 | 13 | 70 | 444 | 514 | 567 |
| 500 | 14 | 70 | 1513 | 1583 | 1834 |
| 500 | 15 | 76 | 1679 | 1755 | 2010 |
| 500 | 16 | 82 | 533 | 615 | 649 |
| 500 | 17 | 83 | 481 | 564 | 630 |
| 500 | 21 | 100 | 538 | 638 | 1045 |
{21}
| 500 | 22 | 100 | 675 | 775 | 864 |
| --- | --- | --- | --- | --- | --- |
| 500 | 23 | 109 | 1446 | 1555 | 1719 |
| 500 | 26 | 123 | 661 | 784 | 816 |
| 500 | 27 | 128 | 503 | 631 | 654 |
| 500 | 28 | 128 | 1221 | 1349 | 1341 |
| 500 | 29 | 141 | 1259 | 1400 | 1667 |
| 500 | 30 | 148 | 942 | 1090 | 1192 |
| 500 | 32 | 160 | 1254 | 1414 | 1940 |
| 500 | 33 | 161 | 1415 | 1576 | 1958 |
| 500 | 34 | 168 | 1319 | 1487 | 2079 |
| 500 | 35 | 168 | 1595 | 1763 | 1839 |
| 500 | 37 | 184 | 548 | 732 | 868 |
| 500 | 39 | 189 | 1067 | 1256 | 1670 |
| 500 | 40 | 200 | 1024 | 1224 | 1439 |
| 500 | 41 | 202 | 393 | 595 | 596 |
| 500 | 43 | 203 | 1230 | 1433 | 1710 |
| 500 | 44 | 211 | 1421 | 1632 | 1767 |
| 500 | 45 | 212 | 1241 | 1453 | 1837 |
| 500 | 46 | 214 | 97 | 311 | 560 |
| 500 | 47 | 231 | 1782 | 2013 | 2952 |
| 500 | 48 | 232 | 207 | 439 | 518 |
| 500 | 49 | 240 | 449 | 689 | 634 |
| 500 | 50 | 246 | 460 | 706 | 636 |
| 500 | 51 | 258 | 1029 | 1287 | 1596 |
| 500 | 52 | 264 | 1642 | 1906 | 3035 |
| 500 | 53 | 270 | 479 | 749 | 744 |
| 500 | 54 | 271 | 1338 | 1609 | 1583 |
| 500 | 55 | 272 | 1080 | 1352 | 1823 |
| 500 | 56 | 273 | 516 | 789 | 685 |
| 500 | 57 | 298 | 2772 | 3070 | 1809 |
| 500 | 58 | 300 | 101 | 401 | 502 |
| 500 | 59 | 307 | 2411 | 2718 | 2183 |
| 500 | 60 | 317 | 2668 | 2985 | 1600 |
| 500 | 61 | 325 | 2828 | 3153 | 1764 |
| 500 | 62 | 330 | 2543 | 2873 | 2309 |
| 500 | 63 | 374 | 693 | 1067 | 1004 |
| 500 | 64 | 380 | 709 | 1089 | 965 |
| 500 | 65 | 402 | 132 | 534 | 765 |
| 500 | 66 | 407 | 747 | 1154 | 1243 |
| 500 | 67 | 417 | 1088 | 1505 | 1934 |
| 500 | 68 | 426 | 1599 | 2025 | 4546 |
{22}
23
| 500 | 69 | 450 | 828 | 1278 | 1391 |
| --- | --- | --- | --- | --- | --- |
| 500 | 71 | 486 | 860 | 1346 | 1398 |
| 500 | 72 | 490 | 1287 | 1777 | 8824 |
| 500 | 73 | 493 | 1005 | 1498 | 1831 |
| 500 | 74 | 494 | 924 | 1418 | 1649 |
| 500 | 75 | 498 | 919 | 1417 | 1356 |
## Qualitative (Total Samples) - 1000 Cutoff (DRI vs. AMP GC/MS)
| New Device (DRI) | Low negative by GC/MS (less than -50%) | Near cutoff negative by GC/MS (between -50% and cutoff) | Near cutoff positive by GC/MS (between cutoff and +50%) | High positive by GC/MS (greater than +50%) | Percent Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Positive | 40 | 15 | 19 | 20 | 97.5% |
| Negative | 35 | 8 | 1 | 0 | 43.9% |
| | Negative GC/MS | Positive GC/MS | Total |
| --- | --- | --- | --- |
| Negative New device (DRI) | 43 | 1 | 44 |
| Positive New device (DRI) | 55 | 39 | 94 |
| Total | 98 | 40 | 138 |
## Discordant Samples
The method comparison samples were categorized based upon the d-amphetamine GC/MS concentration only. The table below identifies those samples with a d-amphetamine GC/MS concentration below the cutoff, in which the observed result on the DRI amphetamines assay was positive.
| Cutoff Value (ng/mL) | Sample # | GC/MS - Amph (ng/mL) | GC/MS - Meth (ng/mL) | GC/MS - Total (ng/mL) | DRI (Neg/Pos) |
| --- | --- | --- | --- | --- | --- |
| 1000 | 2 | 47 | 1653 | 1700 | Pos |
| 1000 | 9 | 68 | 1621 | 1689 | Pos |
| 1000 | 10 | 68 | 334 | 402 | Pos |
{23}
| 1000 | 11 | 69 | 1666 | 1735 | Pos |
| --- | --- | --- | --- | --- | --- |
| 1000 | 12 | 69 | 1707 | 1776 | Pos |
| 1000 | 14 | 70 | 1513 | 1583 | Pos |
| 1000 | 15 | 76 | 1679 | 1755 | Pos |
| 1000 | 21 | 100 | 538 | 638 | Pos |
| 1000 | 23 | 109 | 1446 | 1555 | Pos |
| 1000 | 28 | 128 | 1221 | 1349 | Pos |
| 1000 | 29 | 141 | 1259 | 1400 | Pos |
| 1000 | 30 | 148 | 942 | 1090 | Pos |
| 1000 | 32 | 160 | 1254 | 1414 | Pos |
| 1000 | 33 | 161 | 1415 | 1576 | Pos |
| 1000 | 34 | 168 | 1319 | 1487 | Pos |
| 1000 | 35 | 168 | 1595 | 1763 | Pos |
| 1000 | 39 | 189 | 1067 | 1256 | Pos |
| 1000 | 40 | 200 | 1024 | 1224 | Pos |
| 1000 | 43 | 203 | 1230 | 1433 | Pos |
| 1000 | 44 | 211 | 1421 | 1632 | Pos |
| 1000 | 45 | 212 | 1241 | 1453 | Pos |
| 1000 | 47 | 231 | 1782 | 2013 | Pos |
| 1000 | 51 | 258 | 1029 | 1287 | Pos |
| 1000 | 52 | 264 | 1642 | 1906 | Pos |
| 1000 | 54 | 271 | 1338 | 1609 | Pos |
| 1000 | 55 | 272 | 1080 | 1352 | Pos |
| 1000 | 57 | 298 | 2772 | 3070 | Pos |
| 1000 | 59 | 307 | 2411 | 2718 | Pos |
| 1000 | 60 | 317 | 2668 | 2985 | Pos |
| 1000 | 61 | 325 | 2828 | 3153 | Pos |
| 1000 | 62 | 330 | 2543 | 2873 | Pos |
| 1000 | 66 | 407 | 747 | 1154 | Pos |
| 1000 | 67 | 417 | 1088 | 1505 | Pos |
| 1000 | 68 | 426 | 1599 | 2025 | Pos |
| 1000 | 69 | 450 | 828 | 1278 | Pos |
| 1000 | 71 | 486 | 860 | 1346 | Pos |
| 1000 | 72 | 490 | 1287 | 1777 | Pos |
| 1000 | 73 | 493 | 1005 | 1498 | Pos |
| 1000 | 74 | 494 | 924 | 1418 | Pos |
| 1000 | 75 | 498 | 919 | 1417 | Pos |
| 1000 | 76 | 500 | 1989 | 2489 | Pos |
| 1000 | 77 | 513 | 938 | 1451 | Pos |
{24}
| 1000 | 78 | 522 | 957 | 1479 | Pos |
| --- | --- | --- | --- | --- | --- |
| 1000 | 79 | 541 | 1013 | 1554 | Pos |
| 1000 | 82 | 572 | 1050 | 1622 | Pos |
| 1000 | 83 | 576 | 1052 | 1628 | Pos |
| 1000 | 85 | 595 | 2396 | 2991 | Pos |
| 1000 | 88 | 656 | 2533 | 3189 | Pos |
| 1000 | 89 | 715 | 2415 | 3130 | Pos |
| 1000 | 93 | 771 | 1190 | 1961 | Pos |
| 1000 | 94 | 780 | 287 | 1067 | Pos |
| 1000 | 95 | 814 | 2984 | 3798 | Pos |
| 1000 | 96 | 816 | 0 | 816 | Pos |
| 1000 | 97 | 929 | 0 | 929 | Pos |
| 1000 | 98 | 998 | 367 | 1365 | Pos |
| 1000 | 99 | 1101 | 0 | 1101 | Neg |
Semi-quantitative (Total Samples) - 1000 Cutoff (DRI vs. AMP GC/MS)
| New Device (DRI) | Low negative by GC/MS (less than -50%) | Near cutoff negative by GC/MS (between -50% and cutoff) | Near cutoff positive by GC/MS (between cutoff and +50%) | High positive by GC/MS (greater than +50%) | Percent Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Positive | 41 | 15 | 19 | 20 | 97.5% |
| Negative | 34 | 8 | 1 | 0 | 42.9% |
| | Negative GC/MS | Positive GC/MS | Total |
| --- | --- | --- | --- |
| Negative New device (DRI) | 42 | 1 | 43 |
| Positive New device (DRI) | 56 | 39 | 95 |
| Total | 98 | 40 | 138 |
# Discordant Samples
The method comparison samples were categorized based upon the d-amphetamine GC/MS concentration only. The table below identifies those samples with a d-amphetamine GC/MS concentration below the cutoff, in which the observed result on the DRI amphetamines assay was positive.
{25}
| Cutoff Value (ng/mL) | Sample # | GC/MS - Amph (ng/mL) | GC/MS - Meth (ng/mL) | GC/MS - Total (ng/mL) | DRI (Neg/Pos) |
| --- | --- | --- | --- | --- | --- |
| 1000 | 2 | 47 | 1653 | 1700 | 1661 |
| 1000 | 9 | 68 | 1621 | 1689 | 1709 |
| 1000 | 10 | 68 | 334 | 402 | 1462 |
| 1000 | 11 | 69 | 1666 | 1735 | 1731 |
| 1000 | 12 | 69 | 1707 | 1776 | 1711 |
| 1000 | 14 | 70 | 1513 | 1583 | 1834 |
| 1000 | 15 | 76 | 1679 | 1755 | 2010 |
| 1000 | 21 | 100 | 538 | 638 | 1045 |
| 1000 | 23 | 109 | 1446 | 1555 | 1719 |
| 1000 | 28 | 128 | 1221 | 1349 | 1341 |
| 1000 | 29 | 141 | 1259 | 1400 | 1667 |
| 1000 | 30 | 148 | 942 | 1090 | 1192 |
| 1000 | 32 | 160 | 1254 | 1414 | 1940 |
| 1000 | 33 | 161 | 1415 | 1576 | 1958 |
| 1000 | 34 | 168 | 1319 | 1487 | 2079 |
| 1000 | 35 | 168 | 1595 | 1763 | 1839 |
| 1000 | 39 | 189 | 1067 | 1256 | 1670 |
| 1000 | 40 | 200 | 1024 | 1224 | 1439 |
| 1000 | 43 | 203 | 1230 | 1433 | 1710 |
| 1000 | 44 | 211 | 1421 | 1632 | 1767 |
| 1000 | 45 | 212 | 1241 | 1453 | 1837 |
| 1000 | 47 | 231 | 1782 | 2013 | 2952 |
| 1000 | 51 | 258 | 1029 | 1287 | 1596 |
| 1000 | 52 | 264 | 1642 | 1906 | 3035 |
| 1000 | 54 | 271 | 1338 | 1609 | 1583 |
| 1000 | 55 | 272 | 1080 | 1352 | 1823 |
| 1000 | 57 | 298 | 2772 | 3070 | 1809 |
| 1000 | 59 | 307 | 2411 | 2718 | 2183 |
| 1000 | 60 | 317 | 2668 | 2985 | 1600 |
| 1000 | 61 | 325 | 2828 | 3153 | 1764 |
| 1000 | 62 | 330 | 2543 | 2873 | 2309 |
| 1000 | 63 | 374 | 693 | 1067 | 1004 |
| 1000 | 66 | 407 | 747 | 1154 | 1243 |
| 1000 | 67 | 417 | 1088 | 1505 | 1934 |
| 1000 | 68 | 426 | 1599 | 2025 | 4546 |
| 1000 | 69 | 450 | 828 | 1278 | 1391 |
{26}
27
| 1000 | 71 | 486 | 860 | 1346 | 1398 |
| --- | --- | --- | --- | --- | --- |
| 1000 | 72 | 490 | 1287 | 1777 | 8824 |
| 1000 | 73 | 493 | 1005 | 1498 | 1831 |
| 1000 | 74 | 494 | 924 | 1418 | 1649 |
| 1000 | 75 | 498 | 919 | 1417 | 1356 |
| 1000 | 76 | 500 | 1989 | 2489 | 45791 |
| 1000 | 77 | 513 | 938 | 1451 | 1589 |
| 1000 | 78 | 522 | 957 | 1479 | 1818 |
| 1000 | 79 | 541 | 1013 | 1554 | 1662 |
| 1000 | 82 | 572 | 1050 | 1622 | 1823 |
| 1000 | 83 | 576 | 1052 | 1628 | 1721 |
| 1000 | 85 | 595 | 2396 | 2991 | 3655 |
| 1000 | 88 | 656 | 2533 | 3189 | 1880 |
| 1000 | 89 | 715 | 2415 | 3130 | 1785 |
| 1000 | 93 | 771 | 1190 | 1961 | 4848 |
| 1000 | 94 | 780 | 287 | 1067 | 1441 |
| 1000 | 95 | 814 | 2984 | 3798 | 3117 |
| 1000 | 96 | 816 | 0 | 816 | 1218 |
| 1000 | 97 | 929 | 0 | 929 | 1047 |
| 1000 | 98 | 998 | 367 | 1365 | 1651 |
## Qualitative (Total Samples) - 500 Cutoff (DRI vs. MAMP GC/MS)
| New Device (DRI) | Low negative by GC/MS (less than -50%) | Near cutoff negative by GC/MS (between -50% and cutoff) | Near cutoff positive by GC/MS (between cutoff and +50%) | High positive by GC/MS (greater than +50%) | Percent Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Positive | 3 | 11 | 11 | 60 | 100.0% |
| Negative | 19 | 7 | 0 | 0 | 65.0% |
| | Negative GC/MS | Positive GC/MS | Total |
| --- | --- | --- | --- |
| Negative New device (DRI) | 26 | 0 | 26 |
| Positive New device (DRI) | 14 | 71 | 85 |
| Total | 40 | 71 | 111 |
{27}
# Discordant Samples
The method comparison samples were categorized based upon the d-methamphetamine GC/MS concentration only. The table below identifies those samples with a d-methamphetamine GC/MS concentration below the cutoff, in which the observed result on the DRI amphetamines assay was positive.
| Cutoff Value (ng/mL) | Sample # | GC/MS -Amph (ng/mL) | GC/MS -Meth (ng/mL) | GC/MS -Total (ng/mL) | DRI (Neg/Pos) |
| --- | --- | --- | --- | --- | --- |
| 500 | 16 | 101 | 300 | 401 | Pos |
| 500 | 17 | 132 | 402 | 534 | Pos |
| 500 | 21 | 207 | 232 | 439 | Pos |
| 500 | 23 | 287 | 780 | 1067 | Pos |
| 500 | 27 | 334 | 68 | 402 | Pos |
| 500 | 29 | 339 | 1142 | 1481 | Pos |
| 500 | 30 | 356 | 1203 | 1559 | Pos |
| 500 | 31 | 367 | 998 | 1365 | Pos |
| 500 | 34 | 393 | 202 | 595 | Pos |
| 500 | 36 | 444 | 70 | 514 | Pos |
| 500 | 37 | 449 | 240 | 689 | Pos |
| 500 | 38 | 460 | 246 | 706 | Pos |
| 500 | 39 | 479 | 270 | 749 | Pos |
| 500 | 40 | 481 | 83 | 564 | Pos |
Semi-quantitative (Total Samples) - 500 Cutoff (DRI vs. MAMP GC/MS)
| New Device (DRI) | Low negative by GC/MS (less than -50%) | Near cutoff negative by GC/MS (between -50% and cutoff) | Near cutoff positive by GC/MS (between cutoff and +50%) | High positive by GC/MS (greater than +50%) | Percent Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Positive | 3 | 11 | 11 | 60 | 100.0% |
| Negative | 19 | 7 | 0 | 0 | 65.0% |
{28}
| | Negative GC/MS | Positive GC/MS | Total |
| --- | --- | --- | --- |
| Negative New device (DRI) | 26 | 0 | 26 |
| Positive New device (DRI) | 14 | 71 | 85 |
| Total | 40 | 71 | 111 |
# Discordant Samples
The method comparison samples were categorized based upon the d-methamphetamine GC/MS concentration only. The table below identifies those samples with a d-methamphetamine GC/MS concentration below the cutoff, in which the observed result on the DRI amphetamines assay was positive.
| Cutoff Value (ng/mL) | Sample # | GC/MS -Amph (ng/mL) | GC/MS -Meth (ng/mL) | GC/MS -Total (ng/mL) | DRI (Neg/Pos) |
| --- | --- | --- | --- | --- | --- |
| 500 | 16 | 101 | 300 | 401 | 502 |
| 500 | 17 | 132 | 402 | 534 | 765 |
| 500 | 21 | 207 | 232 | 439 | 518 |
| 500 | 23 | 287 | 780 | 1067 | 1441 |
| 500 | 27 | 334 | 68 | 402 | 1462 |
| 500 | 29 | 339 | 1142 | 1481 | 1810 |
| 500 | 30 | 356 | 1203 | 1559 | 1797 |
| 500 | 31 | 367 | 998 | 1365 | 1651 |
| 500 | 34 | 393 | 202 | 595 | 596 |
| 500 | 36 | 444 | 70 | 514 | 567 |
| 500 | 37 | 449 | 240 | 689 | 634 |
| 500 | 38 | 460 | 246 | 706 | 636 |
| 500 | 39 | 479 | 270 | 749 | 744 |
| 500 | 40 | 481 | 83 | 564 | 630 |
Qualitative (Total Samples) - 1000 Cutoff (DRI vs. MAMP GC/MS)
| New Device (DRI) | Low negative by GC/MS (less than | Near cutoff negative by GC/MS (between -50% and | Near cutoff positive by GC/MS (between cutoff and | High positive by GC/MS (greater than +50%) | Percent Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| | ng/mL) | ng/mL) | ng/mL) | | |
| 500 | 16 | 101 | 300 | 401 | 502 |
| 500 | 17 | 132 | 402 | 534 | 765 |
| 500 | 21 | 207 | 232 | 439 | 518 |
| 500 | 23 | 287 | 780 | 1067 | 1441 |
| 500 | 27 | 334 | 68 | 402 | 1462 |
| 500 | 29 | 339 | 1142 | 1481 | 1810 |
| 500 | 30 | 356 | 1203 | 1559 | 1797 |
| 500 | 31 | 367 | 998 | 1365 | 1651 |
| 500 | 34 | 393 | 202 | 595 | 596 |
| 500 | 36 | 444 | 70 | 514 | 567 |
| 500 | 37 | 449 | 240 | 689 | 634 |
| 500 | 38 | 460 | 246 | 706 | 636 |
| 500 | 39 | 479 | 270 | 749 | 744 |
| 500 | 40 | 481 | 83 | 564 | 630 |
{29}
| | -50%) | cutoff) | +50%) | | |
| --- | --- | --- | --- | --- | --- |
| Positive | 5 | 9 | 22 | 31 | 100.0% |
| Negative | 35 | 9 | 0 | 0 | 75.9% |
| | Negative GC/MS | Positive GC/MS | Total |
| --- | --- | --- | --- |
| Negative New device (DRI) | 44 | 0 | 44 |
| Positive New device (DRI) | 14 | 53 | 67 |
| Total | 58 | 53 | 111 |
# Discordant Samples
The method comparison samples were categorized based upon the d-methamphetamine GC/MS concentration only. The table below identifies those samples with a d-methamphetamine GC/MS concentration below the cutoff, in which the observed result on the DRI amphetamines assay was positive.
| Cutoff Value (ng/mL) | Sample # | GC/MS -Amph (ng/mL) | GC/MS -Meth (ng/mL) | GC/MS -Total (ng/mL) | DRI (Neg/Pos) |
| --- | --- | --- | --- | --- | --- |
| 1000 | 23 | 287 | 780 | 1067 | Pos |
| 1000 | 27 | 334 | 68 | 402 | Pos |
| 1000 | 29 | 339 | 1142 | 1481 | Pos |
| 1000 | 30 | 356 | 1203 | 1559 | Pos |
| 1000 | 31 | 367 | 998 | 1365 | Pos |
| 1000 | 45 | 538 | 100 | 638 | Pos |
| 1000 | 49 | 693 | 374 | 1067 | Pos |
| 1000 | 51 | 747 | 407 | 1154 | Pos |
| 1000 | 52 | 828 | 450 | 1278 | Pos |
| 1000 | 53 | 860 | 486 | 1346 | Pos |
| 1000 | 54 | 919 | 498 | 1417 | Pos |
| 1000 | 55 | 924 | 494 | 1418 | Pos |
| 1000 | 56 | 938 | 513 | 1451 | Pos |
| 1000 | 57 | 942 | 148 | 1090 | Pos |
| 1000 | 58 | 957 | 522 | 1479 | Pos |
Semi-Quantitative (Total Samples) - 1000 Cutoff (DRI vs.
{30}
MAMP GC/MS)
| New Device (DRI) | Low negative by GC/MS (less than -50%) | Near cutoff negative by GC/MS (between -50% and cutoff) | Near cutoff positive by GC/MS (between cutoff and +50%) | High positive by GC/MS (greater than +50%) | Percent Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Positive | 5 | 10 | 22 | 31 | 100.0% |
| Negative | 35 | 8 | 0 | 0 | 74.1% |
| | Negative GC/MS | Positive GC/MS | Total |
| --- | --- | --- | --- |
| Negative New device (DRI) | 43 | 0 | 43 |
| Positive New device (DRI) | 15 | 53 | 68 |
| Total | 58 | 53 | 111 |
## Discordant Samples
The method comparison samples were categorized based upon the d-methamphetamine GC/MS concentration only. The table below identifies those samples with a d-methamphetamine GC/MS concentration below the cutoff, in which the observed result on the DRI amphetamines assay was positive.
| Cutoff Value (ng/mL) | Sample # | GC/MS - Amph (ng/mL) | GC/MS - Meth (ng/mL) | GC/MS - Total (ng/mL) | DRI (Neg/Pos) |
| --- | --- | --- | --- | --- | --- |
| 1000 | 23 | 287 | 780 | 1067 | 1441 |
| 1000 | 27 | 334 | 68 | 402 | 1462 |
| 1000 | 29 | 339 | 1142 | 1481 | 1810 |
| 1000 | 30 | 356 | 1203 | 1559 | 1797 |
| 1000 | 31 | 367 | 998 | 1365 | 1651 |
| 1000 | 45 | 538 | 100 | 638 | 1045 |
| 1000 | 49 | 693 | 374 | 1067 | 1004 |
| 1000 | 51 | 747 | 407 | 1154 | 1243 |
| 1000 | 52 | 828 | 450 | 1278 | 1391 |
| 1000 | 53 | 860 | 486 | 1346 | 1398 |
{31}
| 1000 | 54 | 919 | 498 | 1417 | 1356 |
| --- | --- | --- | --- | --- | --- |
| 1000 | 55 | 924 | 494 | 1418 | 1649 |
| 1000 | 56 | 938 | 513 | 1451 | 1589 |
| 1000 | 57 | 942 | 148 | 1090 | 1192 |
| 1000 | 58 | 957 | 522 | 1479 | 1818 |
b. Matrix comparison:
Not applicable, human urine is the only sample matrix used.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
